This invention relates to transporting substances across a biological membrane of an animal, such as a human, and particularly to a device and method for forming openings in the biological membrane for delivering substances into the animal through the biological membrane for treatment applications or extracting sub stances from the animal through the biological membrane for monitoring or other diagnosis applications.
There are many techniques known in the art for making openings or holes in biological membranes, such as skin, for drug delivery and monitoring applications. One well known example of the need in the art for less painful puncturing of a biological membrane is in the field of diabetes monitoring. Diabetes patients often must submit to painful finger sticks, sometimes several times a day, with lancets and micro-lancets in order to obtain an adequate quantity of fluid. Other than the relative size of the lancets decreasing, the use of lancets, and the resulting finger sensitivity and pain, has not changed for many years. Other techniques have been developed, such as the use of laser, hydraulic jets, or electroporation, with the purpose of minimizing the pain and invasiveness of the procedure. See, for example, commonly assigned U.S. Pat. No. 5,885,211 to Eppstein et al, which is directed to thermal microporation techniques and devices to form one or more micropores in a biological membrane.
Each of these technologies have their associated advantages and disadvantages, and accordingly, other techniques are being developed that may prove to have broad application in all transmembrane transport applications.
Briefly, the present invention is directed to a method and apparatus for forming artificial openings in a selected area of a biological membrane using a pyrotechnic element that is triggered to explode in a controlled fashion so that the micro-explosion produces the artificial opening in the biological membrane to a desired depth and diameter. The method and apparatus of the present invention is suitable for use in connection with analyte monitoring whereby access to a biological fluid is gained through the at least one opening. Likewise, this technique is useful for transmembrane delivery applications where it is desirable to delivery substances through the membrane into the organism.
The above and other objects and advantages of the present invention will become more readily apparent when reference is made to the following description taken in conjunction with the accompanying drawings.